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Data Presented at the American Psychiatric Association Annual Meeting Supports Gender-Specific Dosing of Intermezzo® (zolpidem tartrate) Sublingual Tablets CIV
Date:5/8/2012

has difficulty returning to sleep. Intermezzo should only be taken if the patient has at least four hours of bedtime remaining before the planned time of waking.

Intermezzo should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. For optimal effect, Intermezzo should not be administered with or immediately after a meal. The blister should be removed from the pouch just prior to dosing.

Each sublingual tablet is individually packaged in a foil blister inside a unit-dose pouch. Before going to bed, a single pouch should be placed by the bedside with a clock or watch nearby. All other unopened Intermezzo pouches should be stored with other medicines away from the bedside. Patients should open the Intermezzo pouch only when they are ready to use it.

Patients can either use the Dosing Time Chart or the Dosing Time Tool that comes with Intermezzo to find the latest time during the night they can take Intermezzo.

Dosing Time Tool: Patients turn a wheel to find the earliest time they must be awake, which corresponds with instructions to take Intermezzo before a specified time.

Dosing Time Chart: The chart helps patients locate the earliest time they need to be awake and match it to the latest time they can take Intermezzo.

When patients wake in the morning, they should make sure that at least four hours have passed since they took Intermezzo and they feel fully awake before driving or engaging in other activities requiring full mental alertness.  Patients should not do dangerous activities until they know how Intermezzo affects them.

Additional Important Safety Information
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.

Cases of angioedema involving the tongue, glottis, or larynx have been reported in patients
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SOURCE Purdue Pharma L.P.
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